Friday, January 22, 2010

HCNN-PDR drug alert


The Health Care Notification Network (HCNN) has issued a copy of the following "Dear Healthcare Provider" from Genentech:

IMPORTANT SAFETY INFORMATION
Regarding ACTEMRA® (tocilizumab)
The purpose of this letter is to inform you of important safety information for ACTEMRA® (tocilizumab), a new interleukin-6 (IL-6) receptor inhibitor that has been approved by the Food and Drug Administration (FDA) for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies.

ACTEMRA targets IL-6. FDA has determined that a Risk Evaluation and Mitigation Strategy (REMS) is necessary for ACTEMRA to ensure that the benefits of the drug outweigh the potential risks of serious infections, gastrointestinal perforations, changes in liver function, decreases in peripheral neutrophil counts, decreases in platelet counts, elevations in lipid parameters in peripheral blood, demyelinating disorders and malignancies.

To read the full letter, click here.

No comments:

Post a Comment

Blog Widget by LinkWithin